SBE — Digital Physical/Chemical Sterilization Process Sensor Class II
FDA product code SBE covers "Digital Physical/Chemical Sterilization Process Sensor", a Class II medical device regulated under 21 CFR 880.2801. Submissions are reviewed by the General Hospital panel.
Classification Details
- Product Code
- SBE
- Device Class
- Class II
- Regulation Number
- 880.2801
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
A digital physical/chemical sterilization process sensor is a device intended to monitor one or more parameter(s) of the sterilization process. The adequacy of the sterilization conditions as measured by the parameter(s) is/are indicated by a digital readout of the result.